Post Market TRUST Study

Not Applicable

Completed

• Conditions: Uterine Fibroids
• Interventions: Procedure: Global Fibroid Ablation (GFA); Procedure: Uterine Artery Embolization (UAE); Procedure: Abdominal or Laparoscopic Myomectomy

• Registration Number: NCT01563783
• Lead Sponsor: Acessa Health, Inc.

Brief Summary

This Post Market study is being conducted to compare the direct and indirect cost of three approaches (GFA, myomectomy, and uterine artery embolization) for the treatment of symptomatic uterine fibroids.

Detailed Description

Uterine fibroids are the most common pelvic neoplasms in women; they severely impact quality of life and are the leading indication for hysterectomy. Hysterectomy is the definitive treatment for myomas; however, many patients seek alternative uterine-sparing therapy and desire to conserve their fertility. Myomectomy is a much-reported surgical option for women with symptomatic fibroids and, until recently, the abdominal approach has been the approach of choice for most surgeons. Over time, patients have requested less invasive procedures and minimally invasive, laparoscopic options are becoming more popular among patients and their gynecologists. Standard surgical and interventional treatments for uterine fibroids are costly to society and to the health care system. New technologies such as GFA may offer a low-cost alternative to the standard treatments for symptomatic uterine fibroids in women who desire uterine conservation. This study seeks to evaluate those cost differences between three available uterine-sparing techniques and to explore the qualitative outcomes such as symptom severity, health related quality of life, and overall treatment effect.

Study Timeline

• Study First Submitted: 2012-03-22
• Study First Submitted QC: 2012-03-23
• Study First Posted: 2012-03-27
• Study Start: 2012-12
• Primary Completion: 2017-09
• Study Completion: 2022-06
• Status Verified: 2023-01
• Last Update Submitted: 2023-01-31
• Last Update Posted: 2023-02-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 84

Inclusion Criteria

• Are ≥ 18 years old and menstruating
• Have symptomatic uterine fibroids
• Have a uterine size ≤ 16 gestational weeks as determined by pelvic exam
• Have all fibroids that are less than 10 cm in any diameter
• Desire uterine conservation
• Have had a normal Pap smear within the past 36 months defined as "no untreated cervical malignancy or dysplasia."
• Are willing and able to comply with all study tests, procedures, and assessment tools
• Are capable of providing informed consent.

Exclusion Criteria

• Have contraindications for laparoscopic surgery and/or general anesthesia.
• Are expected to be high risk for, or are known to have, significant intra-abdominal adhesions (defined as adhesions that would require extensive dissection to mobilize and view all surfaces of the uterus)
• Patients requiring major elective concomitant procedures (e.g., hernia repair)
• Are pregnant or lactating
• Have taken any depot GnRh agonist within three months prior to the screening procedures
• Have an implanted intrauterine or fallopian tube device for contraception that cannot or will not be removed at least 10 days prior to treatment
• Have chronic pelvic pain known to not be due to uterine fibroids
• Have known or suspected endometriosis Stage 3 or 4, adenomyosis
• Have active or history of pelvic inflammatory disease
• Have a history of, or evidence of, gynecologic malignancy or pre-malignancy within the past five years
• Have had pelvic radiation
• Have a non-uterine pelvic mass over 3 cm
• Have a cervical myoma
• Have one or more completely intracavitary submucous fibroids (Type 0) or only Type 0/1 submucous fibroids that are better treated via hysteroscopic methods
• In the medical judgment of the investigator should not participate in the study
• Are not willing to be randomized to treatment.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Woman Suitable for UAE or GFA	Global Fibroid Ablation (GFA)	This group will consist of women who desire uterine preservation. Women will be randomized 1:1 to GFA or uterine artery embolization (UAE).
Woman Suitable for Myomectomy or GFA	Global Fibroid Ablation (GFA)	This group will consist of women who desire uterine preservation. Women will be randomized 1:1 to GFA or Myomectomy (laparoscopic or abdominal).
Woman Suitable for UAE or GFA	Uterine Artery Embolization (UAE)	This group will consist of women who desire uterine preservation. Women will be randomized 1:1 to GFA or uterine artery embolization (UAE).
Woman Suitable for Myomectomy or GFA	Abdominal or Laparoscopic Myomectomy	This group will consist of women who desire uterine preservation. Women will be randomized 1:1 to GFA or Myomectomy (laparoscopic or abdominal).

Primary Outcome Measures

Name	Time	Method
Compare direct cost of GFA compared to those of myomectomy and UAE	3 months post procedure	To compare medical, surgical, and hospitalization costs (including procedural complication costs) of Global Fibroid Ablation (GFA) compared to those of Myomectomy and Uterine Artery Embolization (UAE)at 3 months post procedure.
Compare rates of acute and near-term serious complications to the acute and near-term treatment-related serious adverse events of pivotal study.	3 months post procedure	Overall rates of acute (within 48 hours post procedure) and near-term (between 2 and 30 days post procedure) serious complications in all GFA subjects compared to the acute and near-term treatment-related serious adverse event rates in the pivotal study.

Secondary Outcome Measures

Name	Time	Method
Assess factors that influence indirect costs of the three treatment alternatives	60 Months	Compare incidence costs of post discharge procedure-related complications and re-interventions we well as indirect cost factors defined as days to return-to-work, return to normal activities of daily living, and cost of care up to 60 months post discharge.
Assess subject's satisfaction with her treatment	60 Months	Compare subject's satisfaction and general health outcome at 3, 6, 12, 24, 36, 48, and 60 months post procedure as compared to baseline using the EQ-5D (a standardized instrument for use as a measure of health outcome).
Assess UFS-QoL pre-treatment to post treatment in all treatment groups	60 Months	To compare fibroid symptom severity and quality of life scores at 3, 6, 12, 24, 36, 48, and 60 months post procedure as compared to baseline using the Uterine Fibroid Symptom and Health Related Quality of Life (UFS-QoL0 assessment tool.
Assess the comparative safety of the three treatment alternatives	60 Months	Safety measures will be assessed by comparing the complication rate for all three alternatives (GFA, Myomectomy, UAE).
Assess subjects menstrual bleeding using the MIQ	60 Months	Compare subjects menstrual bleeding pre-treatment and up to 3, 6, 12, 24, 36, 48, and 60 months post treatment using the Menorrhagia Impact Questionnaire (MIQ).

Trial Locations

Locations (1)

University of Saskatchewan, Saskatoon City Hospital; 🇨🇦 Saskatoon, Saskatchewan, Canada